Analyte monitoring and management device and method to analyze the frequency of user interaction with the device

ABSTRACT

Methods and Devices to monitor the level of at least one analyte are provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/448,287 filed Apr. 16, 2012, which is a continuation of U.S.patent application Ser. No. 12/147,464 filed Jun. 26, 2008, now U.S.Pat. No. 8,160,900, which claims priority under § 35 U.S.C. 119(e) toU.S. provisional application No. 60/947,026 filed Jun. 29, 2007 entitled“Analyte Monitoring and Management Device and Method to Analyze theFrequency of User Interaction with the Device,” the disclosures of eachof which are incorporated by reference for all purposes.

BACKGROUND

The detection of the level of analytes, such as glucose, lactate,oxygen, and the like, in certain individuals, is vitally important totheir health. For example, the monitoring of glucose is particularlyimportant to individuals with diabetes. Diabetics may need to monitorglucose levels to determine when insulin is needed to reduce glucoselevels in their bodies or when additional glucose is needed to raise thelevel of glucose in their bodies.

A conventional technique used by many diabetics for personallymonitoring their blood glucose level includes the periodic drawing ofblood, the application of that blood to a test strip, and thedetermination of the blood glucose level using colormetric,electrochemical, or photometric detection. This technique does notpermit continuous or automatic monitoring of glucose levels in the body,but typically must be performed manually on a periodic basis.Unfortunately, the consistency with which the level of glucose ischecked varies widely among individuals. Many diabetics find theperiodic testing inconvenient and they sometimes forget to test theirglucose level or do not have time for a proper test.

In vivo glucose sensors that continuously or automatically monitor theindividual's glucose level and enable individuals to more easily monitortheir glucose, or other analyte levels are also commercially available.These systems may provide the user with accurate analyte levels at ten,five or even one minute intervals. Some examples of such systems areillustrated in U.S. Pat. No. 6,175,752, and in U.S. Patent PublicationNo. 2004/0186365 filed Dec. 26, 2003, now U.S. Pat. No. 7,811,231,entitled “Continuous Glucose Monitoring System and Methods of Use.”Devices and systems for management of the analyte level may also beincluded in the analyte monitoring system. An example of an analytemanagement system is an insulin pump, which may manage the analyte levelby, for example, delivering a dose of insulin to the user in response tothe glucose levels of the user. The analyte management system may beautomatic, user controlled, or any combination thereof.

Clinical studies have shown that some patients derive considerablebenefits from an increased frequency of available analyte levels, abenefit provided by the analyte measuring systems. However, otherpatients derived little or no benefit from an increased availability ofanalyte levels. Using glucose monitoring as an example, patients whoderived little or no value from the glucose monitoring systems were atan increased risk of hyperglycemic or hypoglycemic episodes.

Increasingly, research has associated the lack of frequent interactionwith the analyte monitoring system as the reason that some patientspotentially derive reduced value from the analyte monitoring systems. Asa result, there is a need for a system which reminds or encourages theuser to interact with the analyte monitoring system at a minimumfrequency.

SUMMARY

Exemplary embodiments of the present disclosure overcome the abovedisadvantages and other disadvantages not described above and provideadvantages which will be apparent from the following description ofexemplary embodiments of the disclosure. Also, the present disclosure isnot required to overcome the disadvantages described above.

According to one aspect of the present disclosure, there is providedmethods to analyze user interaction with a medical device. Exemplaryembodiments include methods to encourage user interaction with a medicaldevice that may include monitoring a user's actual frequency ofinteraction with the medical device; comparing the user's actualfrequency of interaction with the medical device to at least onepredetermined target level of interaction; and alerting the user whenthe user's actual frequency of interaction with the medical device isequal to or below the at least one predetermined target level ofinteraction.

According to one aspect of the present disclosure, the user may beinformed of the difference between the actual frequency of interactionwith the medical device and the predetermined target level ofinteraction.

According to one aspect of the present disclosure the user may bealerted using an alarm. The alarm may be an audible and/or visual and/orvibrating alarm. According to another aspect of the present disclosure,the audible alarm may increase in loudness over time after beingactivated.

According to one aspect of the present disclosure the method may includea plurality of predetermined target levels of interaction, whereinalerting the user distinguishes between the plurality of target levelsof interaction.

According to one aspect of the present disclosure, the user may berequired to perform at least one step to turn off the alert. Accordingto yet another aspect, the at least one step may be a decision relatedto the user's state of health.

According to one aspect of the present disclosure, the at least onepredetermined target level of interaction may be adjusted by anauthorized user. The at least one predetermined target level ofinteraction may also be adjusted according to a time of day, type ofactivity, or projected future analyte level.

According to another aspect of the present disclosure, the history ofthe user's actual frequency of interaction with the medical device maybe recorded. In this aspect, the at least one predetermined target levelof interaction may be adjusted according to the recorded history.Moreover, the history of the user's actual frequency of interaction withthe medical device may be organized according to behavior variablesinputted by the user. According to another aspect of the presentdisclosure, the at least one predetermined target level of interactionmay be adjusted according to a data received from a sensor located onthe user.

According to one aspect of the present disclosure, the user may berewarded when the actual frequency of interaction stays above the atleast one predetermined level of interaction for a predetermined time.

According to another aspect of the present disclosure, there isdisclosed an analyte monitoring apparatus comprising a sensor which isattached to a user for monitoring an analyte level of the user, thesensor further comprising a transmitter which transmits informationobtained by the sensor; and a receiver unit comprising a receiver forreceiving data from the sensor, and a display coupled to the receiverwhich displays the received data to the user when the user interactswith the receiver unit, wherein the receiver unit monitors the user'sactual frequency of interaction with the device, compares the user'sactual frequency of interaction with the receiver unit to at least onepredetermined target level of interaction, and alerts the user when theuser's actual frequency of interaction with the receiver unit is equalto or below the at least one predetermined target level of interaction.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features and advantages of the present disclosurewill become more apparent from detailed exemplary embodiments set forthhereinafter with reference to the attached drawings in which:

FIG. 1 is a block diagram of an exemplary embodiment of a datamonitoring and management system according to the present disclosure;

FIG. 2 is a block diagram of one exemplary embodiment of a receiverunit, according to the present disclosure;

FIG. 3 is a front view of an exemplary embodiment of a receiver unit;

FIG. 4 is a front view of a second exemplary embodiment of a receiverunit;

FIG. 5 is a front view of a third exemplary embodiment of a receiverunit; and

FIG. 6 is a chart of an analyte monitoring system according to anexemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure will now be described more fully with referenceto the accompanying figures, in which exemplary embodiments of thedisclosure are shown. The figures shown herein are not necessarily drawnto scale, with some components and features being exaggerated forclarity. Like reference numerals in the figures denote like elements.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting, since the scope of the present disclosure will belimited only by the appended claims. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisdisclosure belongs. It must be noted that as used herein and in theappended claims, the singular forms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

Embodiments are described herein generally with respect to in vivoanalyte monitoring device and methods in which at least a portion of ananalyte sensor is positioned beneath a skin surface of a user, wheresuch description is not intended to limit the scope of the disclosure inany way. Also contemplated are in vitro analyte monitoring systems,e.g., small volume (e.g., sample volumes ranging from about 0.1 to about1 microliter), and/or short assay times (e.g., assay times ranging fromabout 1 second to about 10 seconds). In vitro systems usually include atest strip and a meter to read the test strip. Examples of in vitroanalyte systems include, but are not limited to, FreeStyle® andPrecision® blood glucose monitoring systems from Abbott Diabetes CareInc. Also contemplated are integrated systems in which one or morecomponents of an in vitro system are included in a single housing, e.g.,lance, test strip or meter.

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system 100 in accordancewith certain embodiments. Embodiments of the subject disclosure arefurther described primarily with respect to glucose monitoring devicesand systems, and methods of glucose detection, for convenience only andsuch description is in no way intended to limit the scope of thedisclosure. It is to be understood that the analyte monitoring systemmay be configured to monitor a variety of analytes at the same time orat different times.

Additionally, in one exemplary embodiment the analyte monitoring systemmay include an analyte management system, such as an insulin pump. Thus,it is to be understood that the following description is directed to ananalyte (for example, glucose) monitoring system for convenience onlyand such description is in no way intended to limit the scope of thedisclosure.

Analytes that may be monitored include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine,glucose, glutamine, growth hormones, hormones, ketone bodies, lactate,peroxide, prostate-specific antigen, prothrombin, RNA, thyroidstimulating hormone, and troponin. The concentration of drugs, such as,for example, antibiotics (e.g., gentamicin, vancomycin, and the like),digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may alsobe monitored. In those exemplary embodiments that monitor more than oneanalyte, the analytes may be monitored at the same or different times.

Moreover, the description herein is directed primarily toelectrochemical sensors for convenience only and is in no way intendedto limit the scope of the disclosure. Other sensors and sensor systemsare contemplated. Such include, but are not limited to, optical sensors,colorimetric sensors, and sensors that detect hydrogen peroxide to inferanalyte levels, etc.

Referring to FIG. 1, the analyte monitoring system 100 includes a sensor101, a data processing unit 102 connectable to the sensor 101, and aprimary receiver unit 104, which is configured to communicate with thedata processing unit 102 via a communication link 103. In certainembodiments, the primary receiver unit 104 may be further configured totransmit data to a data processing terminal 105 to evaluate or otherwiseprocess or format data received by the primary receiver unit 104. Thedata processing terminal 105 may be configured to receive data directlyfrom the data processing unit 102 via a communication link which mayoptionally be configured for bi-directional communication. Further, thedata processing unit 102 may include a transmitter or a transceiver totransmit and/or receive data to and/or from the primary receiver unit104 and/or the data processing terminal 105 and/or optionally thesecondary receiver unit 106. In one exemplary embodiment, the primaryreceiver unit 104 may be designed to sit on a shelf or nightstand. Inthis exemplary embodiment, the primary receiver unit 104 may be used byparents to monitor their children while they sleep or to awaken patientsduring the night. In addition, in this exemplary embodiment the primaryreceiver unit may include a lamp or a radio for convenience and/or foractivation as an alarm.

Also shown in FIG. 1 is an optional secondary receiver unit 106 which isoperatively coupled to the communication link and configured tocommunicate with the data processing unit 102. The secondary receiverunit 106 may also be configured to communicate with the primary receiverunit 104, as well as the data processing terminal 105. The secondaryreceiver unit 106 may be configured for bi-directional wirelesscommunication with each of the data processing unit 102, the primaryreceiver unit 104 and the data processing terminal 105. In certainembodiments the secondary receiver unit 106 may be a de-featuredreceiver as compared to the primary receiver, i.e., the secondaryreceiver may include a limited or minimal number of functions andfeatures as compared with the primary receiver unit 104. As such, thesecondary receiver unit 106 may include a smaller (in one or more,including all, dimensions) compact housing or be embodied in a devicesuch as a wrist watch, arm band, etc., for example. Alternatively, thesecondary receiver unit 106 may be configured with the same orsubstantially similar functions and features as the primary receiverunit 104. The secondary receiver unit 106 may also include a dockingportion to be mated with a docking cradle unit for placement by, e.g.,the bedside for night time monitoring, and/or a bi-directionalcommunication device. A docking cradle may recharge a power supply.

Only one sensor 101, data processing unit 102 and data processingterminal 105 are shown in the embodiment of the analyte monitoringsystem 100 illustrated in FIG. 1. However, it will be appreciated by oneof ordinary skill in the art that the analyte monitoring system 100 mayinclude more than one sensor 101, and/or more than one data processingunit 102, and/or more than one data processing terminal 105. Multiplesensors may be positioned in a patient for analyte monitoring at thesame or different times. In certain embodiments, analyte informationobtained by a first positioned sensor may be employed as a comparison toanalyte information obtained by a second sensor. This may be useful toconfirm or validate analyte information obtained from one or both of thesensors. Such redundancy may be useful if analyte information iscontemplated in critical therapy-related decisions. In certainembodiments, a first sensor may be used to calibrate a second sensor, orvice-versa.

The analyte monitoring system 100 may be a continuous monitoring system,or semi-continuous, or a discrete monitoring system. In amulti-component environment, each component may be configured to beuniquely identified by one or more of the other components in the systemso that communication conflict may be readily resolved between thevarious components within the analyte monitoring system 100. Forexample, unique IDs, communication channels, and the like, may be used.

In certain embodiments, the sensor 101 is physically positioned in or onthe body of a user whose analyte level is being monitored. The sensor101 may be configured to at least periodically sample the analyte levelof the user and convert the sampled analyte level into a correspondingsignal for transmission by the data processing unit 102. The dataprocessing unit 102 performs data processing functions, where suchfunctions may include, but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user, for transmission to a receiver unit (104 or 106) via thecommunication link 103. In certain embodiments, one or moreapplication-specific integrated circuits (ASIC) may be used to implementone or more functions or routines associated with the operations of thedata processing unit (and/or receiver unit) using for example one ormore state machines and buffers.

In one embodiment, the sensor 101 or the data processing unit 102 or acombined sensor/data processing unit may be wholly implantable under theskin layer of the user.

In certain embodiments, the primary receiver unit 104 may include ananalog interface section including an RF receiver and an antenna that isconfigured to communicate with the data processing unit 102 via thecommunication link 103, and a data processing section for processing thereceived data from the data processing unit 102 such as data decoding,error detection and correction, data clock generation, data bitrecovery, etc., or any combination thereof.

In operation, the primary receiver unit 104 in certain exemplaryembodiments is configured to synchronize with the data processing unit102 to uniquely identify the data processing unit 102, based on, forexample, an identification information of the data processing unit 102,and thereafter, to periodically receive signals transmitted from thedata processing unit 102 associated with the monitored analyte levelsdetected by the sensor 101.

Referring again to FIG. 1, the data processing terminal 105 may includea personal computer, a portable computer such as a laptop or a handhelddevice (e.g., personal digital assistants (PDAs), telephone such as acellular phone (e.g., a multimedia and Internet-enabled mobile phonesuch as an iPhone or similar phone), mp3 player, pager, and the like),or a drug delivery device (e.g., an insulin pump), each of which may beconfigured for data communication with the receiver via a wired or awireless connection. Additionally, the data processing terminal 105 mayfurther be connected to a data network (not shown) for storing,retrieving, updating, and/or analyzing data corresponding to thedetected analyte level of the user.

In certain embodiments, the communication link 103 as well as one ormore of the other communication interfaces shown in FIG. 1, may use oneor more of: a radio frequency (RF) communication protocol, an infraredcommunication protocol, a Bluetooth® enabled communication protocol, an802.11x wireless communication protocol, or an equivalent wirelesscommunication protocol which would allow secure, wireless communicationof several units (for example, per HIPAA requirements), while avoidingpotential data collision and interference.

The primary receiver unit 104, according to an exemplary embodiment ofthe present disclosure, illustrated in block form in FIG. 2, includes areceiver 20 to receive data from the data processing unit 102, ananalyzer 22 to evaluate the data, a display 24 to provide information tothe user, and an alarm system 26 to warn the user when a conditionarises. The primary receiver unit 104 may also optionally include a datastorage device 28, a transmitter 30, and/or an input device 32. Asdescribed above, the secondary receiver unit 106 may have the samestructure as the primary receiver unit 104, and as such, the followingdescription of receiver unit functions apply equally to the primary andsecondary receiver units.

In one exemplary embodiment, a primary receiver unit 104 may be abedside unit for use at home. The bedside unit may have its own dataanalyzer and data storage. The data may be communicated from the dataprocessing unit 102 or another receiver unit, such as a secondaryreceiver unit 106. Thus, at least one receiver unit contains all therelevant data so that the data can be downloaded and analyzed withoutsignificant gaps.

The receiver 20 may be formed using known receiver and antenna circuitryand may be tuned or tunable to the frequency or frequency band of thedata processing unit 102. In one exemplary embodiment, the receiver 20is capable of receiving signals from a distance greater than thetransmitting distance of the data processing unit 102.

In another embodiment, a repeater unit (not shown) is used to boost asignal from the data processing unit 102 so that the signal can bereceived by receiver units 104 and 106 that may be distant from the dataprocessing unit 102. The repeater unit is typically independent of thedata processing unit 102, but, in some cases, the repeater unit may beconfigured to attach to the data processing unit 102. Typically, therepeater unit includes a receiver for receiving the signals from thedata processing unit 102 and a transmitter for transmitting the receivedsignals. The transmitter of the repeater unit may be more powerful thanthe transmitter of the data processing unit 102 in one exemplaryembodiment of the present disclosure. The repeater unit may be used, forexample, in a child's bedroom for transmitting a signal from a dataprocessing unit 102 on the child to a primary receiver unit 104 in theparent's bedroom for monitoring the child's analyte levels and frequencyof interaction with the secondary receiver unit 106.

A variety of displays 24 may be used, including cathode ray tubedisplays (particularly for larger units), light emitting diode (LED)displays, or liquid crystal display (LCD) displays. The display 24 maybe monochromatic (e.g., black and white) or polychromatic (i.e., havinga range of colors). The display 24 may contain symbols or otherindicators that are activated under certain conditions (e.g., an alertto the user may become visible on the display when the user's frequencyof interaction with the receiver units 104 and 106 falls below thepredetermined target level of interaction). The display 24 may alsocontain more complex structures, such as LCD or LED alphanumericstructures, portions of which can be activated to produce a letter,number, or symbol. For example, the display 24 may include region 34 todisplay numerically the level of the analyte, as illustrated in FIG. 3.

In one exemplary embodiment, as shown in FIG. 5, the display 24 alsoprovides a message 60 to the user to direct the user in an action. Suchmessages may include, for example, “Check Analyte Level”, if the user'sfrequency of interaction with a receiver unit falls below thepredetermined target level. In another exemplary embodiment, themessages may provide helpful hints or tips to the user. The display mayalso include other indicators 36, including directional arrows, etc.,which may be activated under certain conditions. For example, indicator38 of a glucose monitoring device, may be activated if the patient ishyperglycemic. Other indicators may be activated in the cases ofhypoglycemia (40), impending hyperglycemia (42), impending hypoglycemia(44), a malfunction, an error condition, or when calibration of thedevice is required (46). In some embodiments, color coded indicators maybe used. Alternatively, the portion 34 which displays the analyteconcentration, may also include a composite indicator 50 (see FIG. 4),portions of which may be appropriately activated to indicate any of theconditions described above. In another exemplary embodiment, the displaymay be capable of displaying a graph 48 of the analyte level over aperiod of time, as illustrated in FIG. 4.

One example of a receiver unit (104 or 106) is illustrated in FIG. 3.The display 24 of this particular receiver unit (104 or 106) includes aportion 34 that displays the level of the analyte, for example, theblood glucose concentration. In one embodiment, the screen may be blankor dark when in the resting state. In this exemplary embodiment, thescreen may be activated if the user interacts with the device. Inanother embodiment, the receiver unit (104 or 106) indicates the time ofday on the default screen, and the user may view the current analytelevel by interacting with the receiver unit (104 or 106), for example bypressing a button or the like on the receiver unit (104 or 106), whichwill display the current analyte level. In this way, receiver units 104and 106 can monitor the frequency of interaction between the user andthe receiver units 104 and 106.

In one exemplary embodiment, the user's interaction with the receiverunits 104 and 106 is system specific. That is, the receiver units 104and 106 update each other when the user interacts with one of thereceiver units (either 104 or 106). In this embodiment, the user needsto only interact with one unit to maintain the target level ofinteraction.

In another embodiment, the user's interaction with the receiving units104 and 106 may be receiver unit specific. One example where the user'sinteraction with the receiver is receiver unit specific may be aguardian/child relationship. In this example, the child's level ofinteraction (with, for example, the primary receiver 104) and theguardian's level of interaction (with, for example, the secondaryreceiver 106) should be assessed independently.

In another exemplary embodiment, as illustrated in FIG. 5, the display24 may display a bar graph 62, or any other suitable indicator,comparing the user's frequency of interaction with the receiver units104 and 106 to the predetermined target frequency. Additionally, asshown in FIG. 5, the display 24 may further be capable of displaying ananalyte indicator 64, which may indicate the rate of change of theanalyte, and the direction of change of the analyte, e.g., by theparticular direction of an arrow or the like. In this exemplaryembodiment, the analyte indicator 64 may point in different directions,such as for example, around a 360 degree clock. Other examples of graphsmay include graphs of the user's frequency of interaction with thereceiver unit (104 or 106), or units (104 and 106), over a period oftime, and graphs of the rate of change or acceleration in the rate ofchange of the analyte level over time.

In some exemplary embodiments, the receiver unit is configured so thatthe user may choose the particular display (e.g., blood glucoseconcentration or graph of concentration versus time) that the userwishes to view. The user may choose the desired display mode by pushinga button or the like, for example, on an optional input device 32. Whenthe user interacts with the device, to view or choose a particulardisplay or to wake the device from its resting state, the receiver unit104 or 106 may record the date and time of the user's interaction withthat receiver unit. In this way, the receiver units 104 and 106 canmonitor the frequency of user interaction with the receiver units. Theoptional input device 32 for interacting with the receiver units 104 and106 will be described in greater detail below.

The above-described graphs benefit both the user and the health careprovider (“HCP”). The user can benefit from subtle behavioralmodification as the graphs and/or screen prompts encourage more frequentinteraction with the device and the expected improvement in outcomes.

HCPs may benefit from more cumulative statistics (such as averageglucose views per day, average glucose views before/after meals, averageglucose views on “in-control” vs. “out-of-control” days or time of day)which may be obtained from the record of user's interaction frequencywith the device and which can be used to understand why a patient maynot be realizing expected gains from the analyte monitoring system. Ifan HCP sees that a patient is not benefiting as expected from theanalyte monitoring system, they may recommend an increased level ofinteraction (e.g., increase interaction target level).

In one exemplary embodiment, the receiver units 104 and 106 may includesoftware. In this exemplary embodiment, each instance of userinteraction, by pressing a button or the like, with a receiver unit 104or 106, or both receiver units 104 and 106, may be recorded. Thesoftware may associate each instance of user interaction with the dateand time of that interaction. For example, the software may record eachinstance that the user queries the main screen of the receiver unit 104or 106. In this exemplary embodiment, the receiver unit 104 or 106 mayfurther include an algorithm for comparing the frequency of userinteraction with the receiver to a predetermined frequency ofinteraction. In this exemplary embodiment, if the frequency of a user'sinteraction with the receiver units 104 and 106 matches or falls belowthe predetermined level of interaction, the receiver unit (104 or 106)may alert the user through an audible or vibratory alert. The alertsystem will be described in greater detail below.

In another exemplary embodiment of the present disclosure, the receiverunits 104 and 106 may also contain software designed to encourageinteraction with the receiver units. For example, the software may settarget rates for the user, so that the user strives to achieve a desiredinteraction frequency with the receiver unit. In another exemplaryembodiment, the software may offer educational information related totreatment as well as helpful hints and tips, thereby educating the useras to the importance of maintaining a predetermined target level ofinteraction with the receiver unit.

In yet another embodiment, the receiver units 104 and 106 may includesoftware that prompts user interaction, e.g., an electronic game, orcartoon-like character, or the like, that requires feedback from theuser. In one exemplary embodiment, the cartoon-like character or thelike may have a “health bar” or a “life bar” which would represent thelevel of interaction between the user and the analyte monitoring system100. That is, by frequently interacting with the cartoon-like character,the user will keep the health, or life, level of the cartoon-likecharacter above the predetermined target level. In one exemplaryembodiment, the user may “feed” the cartoon-like character byinteracting with the device. The user's analyte level, or other relevantinformation should also be displayed on the screen of the device duringinteraction between the user and the cartoon-like character. In oneexemplary embodiment, the user will be limited in the amount ofinteraction in a predetermined time. That is, the user will not be ableto front-load the amount of interaction with the device, and then ignorethe device for a prolonged period of time. As such, the device may onlyrecord a predetermined number of interactions within a certain period oftime.

By interacting with the cartoon-like character, the user may also beeducated as to the benefits of maintaining a proper target rate ofinteraction with the device, or may at least stay informed as to his ownstate of health. This embodiment may be particularly interesting tochildren as it may help ensure that children maintain the necessarylevel of interaction with the monitoring device of this disclosure. Thisexemplary embodiment may also be coupled with education regardingtreatment options, helpful hints and tips. Moreover, the above-describedembodiment need not be used with a continuous glucose monitoring (“CGM”)device.

In one exemplary embodiment of the present disclosure, the above conceptcan also be adapted to the “finger stick test.” Using glucose as anexample, the user may interact with the cartoon-like character bymanually checking his blood glucose level. That is, each time the usermanually checks his glucose level, using the finger stick test, thecartoon-like character may gain a point to the “health” or “life” bar.Similar to the embodiment described above, the “health” or “life” barmay represent the target level of user interaction. In this way, theuser will desire to keep the cartoon-like character healthy, and thusinteract with the device at an increased frequency. With regard to theembodiments described above, one of ordinary skill in the art willunderstand that the cartoon-like character is simply an example, andthat any kind of character or figure may be used.

In order to achieve the full benefit of the analyte monitoring system100, the user should maintain a predetermined target rate of interactionwith the system. In one exemplary embodiment, the predetermined targetlevel of user interaction is set by an HCP, or the user's health careteam. Thus, each predetermined target level of interaction will likelydepend on the specific user. However, in one exemplary embodiment,factors affecting the predetermined level of user interaction with thesystem may be: the particular analyte to be measured, the user's generalstate of health, (for example, more frequent during sick days), symptomsexhibited by the user, time of day, time since or until meal, activitylevel and other events.

In one exemplary embodiment, the target level may be programmed (or usermodifiable) to vary during the course of the day or week (work week vs.weekend), with these rates being easily adjustable to account for eventsor changes, such as, during sick days, times of high activity, or othertimes when more frequent interactions should be encouraged. AlthoughHCPs may recommend only general interaction levels (e.g., once per hourduring waking hours), these levels may be tailored to the individualuser. For example, if a user feels overwhelmed with CGM technology,lower target levels of interaction may be needed, whereas a user whofeels empowered by the technology may be encouraged to interact with thedevice at a higher frequency. Generally, HCPs will review interactionlevels during routine visits when assessing general health and reviewingdata uploads (e.g., approximately every 3 months for patients withdiabetes). However, this approach may differ depending on the user, orother factors.

In another exemplary embodiment, the predetermined target level of userinteraction with the receiver units 104 and 106 may be set according tothe time of day. For example, a user may interact with the receiverunits 104 and 106 more frequently during the day than at night.Additionally, in another exemplary embodiment, the predetermined targetlevel of user interaction with the receiver units 104 and 106 may be setaccording to the type of activity being performed by the user. Forexample, a user on a long-distance bicycle ride or car ride may need tocheck the analyte levels more frequently. In one exemplary embodiment,an HCP may recommend target levels of interaction corresponding tovarious events. In another exemplary embodiment, the target level ofuser interaction may be set by the user, or any other authorized party.

In one exemplary embodiment, the system may automatically adjust thetarget level of interaction based upon the user's activity level orstate of general wellness. In this exemplary embodiment, the system mayuse pulse rate, body temperature, respiration rate or other indicatorsto adjust the analyte level. Alternatively, position sensors,accelerometers or the like may be used to detect sleep and reduce (oreven suspend) the target interaction frequency.

In another exemplary embodiment, the analyte monitoring system 100 mayuse the detected analyte levels to adjust future target levels ofinteraction. For example, the system may use an increase in glucoselevel, an increase in the rate of change of the glucose level, userentered information or some other analysis of the measured analyte levelto identify a need to adjust the current target level of interaction. Inone exemplary embodiment, the analyte levels may detect that the userhas recently had a meal and may then adjust the interaction frequencyautomatically to a pre-programmed or user-set level.

Another exemplary embodiment may include a plurality of predeterminedtarget levels of user interaction with the system of the presentdisclosure. For example, the present disclosure may include an “ideal”level of interaction, an “acceptable” level of interaction and a“critical” level of interaction. These levels may shift based on severalfactors. In one exemplary embodiment, the level of interaction may beadjusted to an increased or decreased target level of interaction basedupon the monitoring results, based upon some user interaction with thedevice (e.g., meal or activity level entry), or may be pre-programmed tovary with the time of day or day of the week. The monitoring results mayinclude, analyte levels, the rate of change of analyte levels, etc.

In another exemplary embodiment, the interaction frequency level may berelative to the predetermined target interaction frequency. For example“ideal” may be approximately 90% or more of the target level;“acceptable” may be 70-90% of the target level; and “critical” may bebelow 70% of the target level.

In another exemplary embodiment of the present disclosure, the analytemonitoring system 100 may adjust the predetermined target levels of userinteraction according to the condition of the user. Using glucose as anexample, if the user's level of glucose drops below a certain threshold,the system may alert the user that hypoglycemia may occur. In thisexemplary embodiment, the analyte monitoring system 100 may adjust thetarget rate of user interaction to be more frequent, thus prompting theuser to interact with the device more often, and thus encourage the userto raise his level of glucose to a more acceptable level. Once theglucose level returns to an acceptable level, the system may adjust thetarget interaction rate accordingly.

In the above exemplary embodiment, the system may include a multiplierfor adjusting target levels of user interaction, wherein thepredetermined target rate of interaction is multiplied by apredetermined amount according to the condition reached. In oneexemplary embodiment, a multiplier may be associated with apredetermined target level, such as for example the “critical” targetlevel. In another exemplary embodiment, a multiplier may be associatedwith a specific condition, or analyte level of the user, such as whenthe user is in danger of becoming hypoglycemic.

In another exemplary embodiment, the system may adjust the rate ofinteraction according to predicted future analyte levels. For example,the analyte monitoring system 100 may predict the future analyte levelof a user by monitoring the present rate of change of the user's analytelevel.

As shown in FIG. 2, a receiver unit (104 or 106) may also optionallyinclude an alarm system 26. In one exemplary embodiment, the alarmsystem 26 is triggered when the user's frequency of interaction with thereceiver units 104 and 106 falls below a predetermined target level ofinteraction. In another exemplary embodiment, the alarm system 26 may betriggered when the user's level of interaction matches the predeterminedtarget level of interaction.

The alarm system 26 may contain one or more individual alarms. Each ofthe alarms may be individually activated to indicate one or morepredetermined target levels of user interaction with the receiver units104 and 106. The alarms may be, for example, auditory or visual. Othersensory-stimulating alarm systems may be used, including alarm systemsthat direct the data processing unit 102 to heat, cool, vibrate, orproduce a mild electrical shock. In some embodiments, the alarms areauditory with a different tone, note or volume indicating differentpredetermined target levels of user interaction with the receiver units104 and 106. In one exemplary embodiment of the present disclosure,various tones of the alarm system 26 may indicate varying urgency levelsof a user's need to interact with the receiver units 104 and 106. Forexample, a high volume alarm may indicate a “critical” predeterminedtarget level being reached, while a lower volume alarm might indicatethat the user's frequency of interaction has fallen below the“acceptable” level of interaction with the receiver unit. Visual alarmsmay also use a difference in color or brightness of the display, orindicators on the display, to distinguish between differentpredetermined target levels of user interaction with the receiver units104 and 106. In some embodiments, an auditory alarm system may beconfigured so that the volume of the alarm increases over time until thealarm is deactivated.

In some embodiments, the alarms may be automatically deactivated after apredetermined time period. In other embodiments, the alarms may beconfigured to deactivate only when the user interacts with a receiverunit.

In another exemplary embodiment of the present disclosure, the receiverunits 104 and 106 may include software for requiring the user to performa series of operations in order to silence the alarm. In this exemplaryembodiment, the operations may be therapeutic decision options beingpresented to the user, or may be a series of options related to theuser's state of health. The user would then need to review these optionsand acknowledge understanding by interacting with the device. In certaincases, the alarm may not turn off unless the user acknowledges suchunderstanding.

FIG. 6 shows a chart according to an exemplary embodiment of the analytemonitoring system 100 of the present disclosure. As shown in Step 1 ofFIG. 6, the predetermined target level of interaction is set. Asdiscussed above, this level may be set by a user, an HCP, any otherauthorized person, or may automatically change depending on the factorsdiscussed above. Next, in Step 2, the predetermined target level of userinteraction is compared to the actual level of user interaction. If theuser's actual level of interaction is above the predetermined targetlevel, the system may simply wait. However, if the user's actual levelof interaction falls below the target level, the system moves on to Step3. In Step 3, the system calculates the difference between the actuallevel of user interaction and the predetermined target level.

In the exemplary embodiment shown in FIG. 6, there are three levels ofuser interaction, the “ideal,” the “acceptable” and the “critical” levelof interaction. In this exemplary embodiment, if the user's actual levelof interaction falls below the “ideal” target level of user interaction,the user may be prompted to interact with the device (Step 4A). In oneexemplary embodiment, the device will sound a low volume alarm for apredetermined period of time. That is, in Step 5A, the device willdetermine if the user has interacted with the device, and if the userhas interacted, the alarm is turned off (Step 7A). As described above,the user may interact with the device by pressing a button or the like.If the user has not interacted with the device, the device determineswhether a predetermined period of time has passed (Step 6A), and if ithas, turns off the alarm.

Similarly, if the user's actual level of interaction falls below the“acceptable” target level of interaction, the system will prompt theuser to interact with the device, by sounding an alarm or the like (Step4B). In this example, as shown in Steps 5B and 6B, the alarm will not beturned off until the user has acknowledged the alarm, by pressing abutton or the like.

If the user's actual level of interaction falls below the “critical”target level of interaction, the system will set off a third alarm (Step4C). Similar to the “acceptable” target level, the alarm will not beturned off until the user has acknowledged the alarm (Step 5C).Additionally, to silence an alarm corresponding to the “critical” targetlevel of interaction, the user may be required to perform a series ofoperations (Step 6C). Once the user completes the series of operations,the alarm is turned off (Step 7C).

One of ordinary skill in the art will understand that the analytemonitoring system of FIG. 6 is simply one possible example of the systemaccording to the present disclosure. Steps other than those described inFIG. 6 may be included in the analyte monitoring system, and similarly,the system does not have to include all of the steps shown in FIG. 6. Assuch, FIG. 6 should not limit the present disclosure in any way, and issimply provided as one example of an analyte monitoring system accordingto an embodiment of the present disclosure.

As shown in FIG. 2, the receiver unit (104 or 106) may also include atransmitter 30 which can be used to transmit a signal to activate analarm system (not shown) on the data processing unit 102. In oneexemplary embodiment, the data processing unit 102 may include areceiver for communicating with the receiver units 104 or 106. Inanother exemplary embodiment, the data processing unit 102 may includean alarm system (not shown) such as the one included with the receiverunits 104 and 106, wherein the alarm of the data processing unit 102 maybe activated by a receiver unit (104 or 106).

A receiver unit (104 or 106) may also include a number of optionalitems. One such item may be, for example, a data storage unit 28. Thedata storage unit 28 may be used to store the history of userinteraction with the receiver unit, among other data. The data storageunit 28 may also be useful to store data that may be downloaded toanother receiver unit, such as the primary receiver unit 104.Alternatively, the data may be downloaded to a computer or other datastorage device in a user's home, at an HCP's office, etc., forevaluation of trends in analyte levels.

In one exemplary embodiment, the HCP may use the recorded history ofinteraction to modify the treatment of the user. The storage unit 28 mayalso store behavior variables, such as events, together with the data ofthe particular event. These behavior variables may be generated eitherautomatically by the receiver unit or can, alternatively, be input bythe user. In an exemplary embodiment, the user may also edit the eventhistory. Examples of events may include things such as the user'sactivity level, state of health, medication (e.g., insulin) dosages,meals or any other event that may have an effect on the assessment of atreatment approach and recommendations for treatment modifications ofthe user.

As shown in FIG. 2, another optional component for the receiver unit isan input device 32, such as a keypad or keyboard. The input device 32may allow numeric or alphanumeric input. The input device 32 may alsoinclude buttons, keys, or the like which initiate functions of, and/orprovide input to, the analyte monitoring system 100. Such functions mayinclude interacting with a receiver unit, manually changing the targetlevel of user interaction with the receiver unit, changing the settingsof the receiver unit or entering behavior variables to be used togetherwith the history of user interaction with the receiver unit, but are notlimited to the above.

Referring to FIG. 5, there is provided an exemplary embodiment of areceiver unit. In FIG. 5, the user may interact with the receiver unitusing input options 32 a-d. In one exemplary embodiment, input options32 a and 32 b are used to select the options shown on the display 24,while input options 32 c and 32 d are used to move through lists tohighlight options and change settings. In another exemplary embodiment,a user's interaction with the integrated test strip, used to, forexample, manually check the blood analyte level of a user, can beincluded as part of the user's interaction with the device.

In one exemplary embodiment, the user will have to acknowledge the alarmor message displayed by the receiver unit (104 or 106). In thisexemplary embodiment, a receiver unit (104 or 106) may have a buttonwhich is the default button for acknowledging an alarm or message.However, some alarms may require the user to interact with a buttonother than the default button. Further, in certain exemplaryembodiments, some alarms may require the user to perform a series ofoperations, such as pressing a combination of buttons or the like, inorder to silence the alarm.

Another exemplary embodiment of the input device 32 is a touch screendisplay. The touch screen display may be incorporated into the display24 or may be a separate display. The touch screen display is activatedwhen the user touches the screen at a position indicated by a “softbutton” which corresponds to a desired function.

In addition, the analyte monitoring system 100 may include passwordprotection to prevent the unauthorized transmission of data to aterminal or the unauthorized changing of settings for the system 100. Auser may be prompted by the receiver unit to input a password using theinput device 32 whenever a password-protected function is initiated.

Accordingly, a method in one aspect includes monitoring a user's actualfrequency of interaction with the medical device, comparing the user'sactual frequency of interaction with the medical device to at least onepredetermined target level of interaction, and alerting the user whenthe user's actual frequency of interaction with the medical device isequal to or below the at least one predetermined target level ofinteraction.

In one aspect, alerting the user may indicate a difference between theactual frequency of interaction with the medical device and thepredetermined target level of interaction.

The user may be alerted by an audible alarm, where the audible alarm mayincrease in loudness over time after being activated.

In another aspect, the user may be alerted by a vibrating alarm.

The method in a further embodiment may include a plurality ofpredetermined target levels of interaction, where alerting the userdistinguishes between the plurality of target levels of interaction.

The user may be required to perform at least one step to turn off thealert, where the at least one step may be a decision related to theuser's state of health.

The at least one predetermined target level of interaction may beadjusted by an authorized user.

In a further aspect, the method may include adjusting the at least onepredetermined target level of interaction according to a time of day.

The method may also include adjusting the at least one predeterminedtarget level of interaction according to a type of activity.

Also, the method may still include adjusting the at least onepredetermined target level of interaction according to a future analytelevel of the user, predicted using rate of change data.

Additionally, the method may include recording a history of the user'sactual frequency of interaction with the medical device, where themethod may also include adjusting the at least one predetermined targetlevel of interaction according to the recorded history.

In still yet a further embodiment, the method may include organizing thehistory of the user's actual frequency of interaction with the medicaldevice according to behavior variables inputted by the user.

Further, the method may include rewarding the user when the actualfrequency of interaction stays above the at least one predeterminedlevel of interaction for a predetermined time.

Additionally, the method may include adjusting the at least onepredetermined target level of interaction according to a data receivedfrom a sensor located on the user.

An analyte monitoring system in accordance with another embodimentincludes a user interactive analyte device to monitor at least oneanalyte of a user, and a processor unit coupled to the user interactivedevice to determine the frequency of user interaction with the analytemonitoring device.

The analyte may include glucose.

In still yet a further aspect, the user interactive device may includean in vivo analyte sensor, where the sensor may be configured to atleast be partially positioned under a skin surface of a user.

An analyte monitoring system in accordance with still another embodimentmay include a sensor to monitor an analyte level of the user, atransmitter to transmit information obtained by the sensor, and areceiver unit comprising a receiver to receive data from the sensor, anda display coupled to the receiver to display the received data to theuser when the user interacts with the receiver unit, where the receiverunit monitors the user's actual frequency of interaction with thedevice, compares the user's actual frequency of interaction with thereceiver unit to at least one predetermined target level of interaction,and alerts the user when the user's actual frequency of interaction withthe receiver unit is equal to or below the at least one predeterminedtarget level of interaction.

The system in one aspect may include a data storage unit for storing ahistory of the user's actual interaction with the receiver unit.

The receiver unit may be portable.

The receiver unit may include a user input unit for interacting with thedisplay unit.

Further, the user input unit may be used to change settings of thereceiver unit.

Although the exemplary embodiment of the present disclosure have beendescribed, it will be understood by those skilled in the art that thepresent disclosure should not be limited to the described exemplaryembodiments, but various changes and modifications can be made withinthe spirit and the scope of the present disclosure. Accordingly, thescope of the present disclosure is not limited to the described range ofthe following claims.

What is claimed is:
 1. An analyte monitoring device, comprising: ahousing; a user interface coupled to the housing; and a processor unitcoupled to the user interface, the processor unit configured todetermine a frequency of interaction based on user operation of the userinterface, to compare a user's actual frequency of interaction to atleast one predetermined target level of interaction, to output an alertto notify the user when the user's actual frequency of interaction withthe user interface is below the at least one predetermined target levelof interaction, to modify the at least one predetermined target level ofinteraction based on the user's actual frequency of interaction over apredetermined time period and monitored analyte level during thepredetermined time period, and to display an output indicator on theuser interface when the user's actual frequency of interaction is at orgreater than the at least one predetermined target level of interaction.2. The device of claim 1, wherein the at least one predetermined targetlevel of interaction is programmed to vary during the predetermined timeperiod.
 3. The device of claim 1, wherein the at least one predeterminedtarget level of interaction is programmed to vary according to the timeof day.
 4. The device of claim 1, wherein the at least one predeterminedtarget level of interaction is programmed to vary according to the typeof activity performed by the user during the predetermined time period.5. The device of claim 1, wherein the output indicator displayedincludes information corresponding to the user's actual frequency ofinteraction and the monitored analyte level during the predeterminedtime period.
 6. The device of claim 1, wherein the processor unit isconfigured to increase the predetermined target level of interactionwhen the monitored analyte level falls below a threshold level.
 7. Thedevice of claim 6, wherein the threshold level includes a hypoglycemiclevel.
 8. The device of claim 1, wherein the processor unit isconfigured to monitor for a user input at the user interface to turn offthe outputted alert.
 9. The device of claim 8, wherein the user isrequired to perform at least one step to turn off the outputted alert,wherein the at least one step is a decision related to the user's stateof health.
 10. The device of claim 1, wherein the at least onepredetermined target level of interaction is adjusted by an authorizeduser.
 11. The device of claim 1, further including a memory operativelycoupled to the processor unit, wherein the processor unit is configuredto record in the memory a history of the user's actual frequency ofinteraction.
 12. The device of claim 11, wherein the processor unit isconfigured to adjust the at least one predetermined target level ofinteraction according to the recorded history.
 13. The device of claim11, wherein the processor unit is configured to organize the history ofthe user's actual frequency of interaction according to behaviorvariables inputted by the user.
 14. The device of claim 1, wherein theuser operation corresponding to the actual frequency of interactionincludes the user operation of the user interface to obtain an analytelevel.
 15. The device of claim 14, wherein the processor unit isconfigured to modify the at least one predetermined target level ofinteraction based on the obtained analyte level.